Post by
goldyhawk on Jan 12, 2022 7:29am
DENOVO -- what i'm risking my money on
To be clear “novel devices” are medical devices brought to market via PMA, 510(k) clearance, humanitarian device exemption, De Novo pathways, or emergency use authorization. “Novel or innovative does not simply mean ‘new.’ They address an unmet need, or may be safer or more effective than currently available alternatives. For FDA-approved and FDA-cleared medical devices, innovation, and safety are two sides of the same coin,” wrote Shuren and Maisel.
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request#What_is_a_De_Novo_Classification_Request_